Boryeong Gabapentin Capsule 300 mg

Adult dose

1. Epilepsy 1) Monotherapy and adjunctive therapy in patients aged 13 years and older To achieve a maintenance dose of 900 mg/day as gabapentin, titrate the dose over the first 3 days of treatment as follows: - Day 1: Administer one 300 mg capsule of this medication once daily, or one 100 mg capsule of this medication 3 times daily (gabapentin 300 mg/day) - Day 2: Administer one 300 mg capsule of this medication 2 times daily, or two 100 mg capsules of this medication 3 times daily (gabapentin 600 mg/day) - From Day 3 onward: Administer one 300 mg capsule of this medication 3 times daily, or three 100 mg capsules of this medication 3 times daily (gabapentin 900 mg/day) Alternatively, as an initial dose, one 300 mg capsule of this medication may be administered 3 times daily (gabapentin 900 mg/day). The dose may be increased to 1,200 mg/day as gabapentin, and the total daily dose must not exceed 2,400 mg as gabapentin. (There are insufficient data on the safety and efficacy of doses exceeding 2,400 mg/day as gabapentin.) 2. Neuropathic pain Adults (18 years and older): To achieve a maintenance dose of 900 mg/day as gabapentin, titrate the dose over the first 3 days of treatment as follows: - Day 1: Administer one 300 mg capsule of this medication once daily, or one 100 mg capsule of this medication 3 times daily (gabapentin 300 mg/day) - Day 2: Administer one 300 mg capsule of this medication 2 times daily, or two 100 mg capsules of this medication 3 times daily (gabapentin 600 mg/day) - From Day 3 onward: Administer one 300 mg capsule of this medication 3 times daily, or three 100 mg capsules of this medication 3 times daily (gabapentin 900 mg/day) Alternatively, as an initial dose, one 300 mg capsule of this medication may be administered 3 times daily (gabapentin 900 mg/day). If necessary, the dose may be increased to 1,800 mg/day as gabapentin within one week; the total daily dose must not exceed 3,600 mg as gabapentin. The total daily dose of this medication should be divided into 3 doses. 3. Debilitated patients: In debilitated patients with low body weight or patients following transplantation, the gabapentin dose should be increased in 100 mg increments. 4. Elderly patients: Dose adjustment may be necessary due to age-related decline in renal function (see table). 5. Patients with renal impairment (creatinine clearance ≤80 mL/min) or patients receiving hemodialysis: Dose adjustment is required based on the following table. 1) Dosage for patients with renal impairment: Renal function: Creatinine clearance (mL/min) / Total daily dosea (mg/day) ≥80 / 900∼2,400 50∼79 / 600∼1,800 30∼49 / 300∼900 15∼29 / 150b∼600 <15 / 150b∼300 a: The total daily dose should be divided into 3 doses. b: Administer 3 × 100 mg every 2 days. In patients with creatinine clearance <15 mL/min, the dose should be reduced in proportion to creatinine clearance. 2) Dosage for patients receiving hemodialysis Initial dose: 300∼400 mg of gabapentin is recommended. Maintenance dose: Administer 200∼300 mg of gabapentin after 4 hours of hemodialysis; do not administer this medication on days when hemodialysis is not performed. 6. Method and duration of administration 1) This medication should be swallowed whole with plenty of fluid and may be taken with or without food. When administered 3 times daily, take care that the interval between doses does not exceed 12 hours to prevent recurrence of seizures. 2) If a dose of this medication is missed (if more than 12 hours have elapsed since the last dose), the physician should decide whether an additional dose should be administered to make up for the missed dose. 3) When administered concomitantly with antacids containing magnesium or aluminum, this medication should be taken at least 2 hours after the antacid. This can substantially reduce the decrease in the bioavailability of this medication. 4) The duration of treatment with this medication should depend on clinical need. Treatment of epilepsy generally requires long-term administration. Although there is no evidence of a rebound phenomenon (increased frequency of epileptic seizures due to abrupt discontinuation of treatment), abrupt discontinuation of antiepileptic drugs in patients with epilepsy may cause status epilepticus. If treatment with this medication must be discontinued or it is administered concomitantly with another antiepileptic drug, changes should be made gradually over at least 1 week. 5) The safety and efficacy of treatment for neuropathic pain for more than 5 months have not been evaluated. 6) To reduce the main adverse effects, such as somnolence, dizziness, fatigue, and ataxia, the first dose on Day 1 should be taken at bedtime.

Child dose

1. Epilepsy 2) Adjunctive therapy in children aged 3 to 12 years — Day 1: Administer gabapentin 10 mg/kg body weight. 2) Adjunctive therapy in children aged 3 to 12 years — Day 2: Administer gabapentin 20 mg/kg body weight. 2) Adjunctive therapy in children aged 3 to 12 years — From Day 3 onward: Administer gabapentin 30 mg/kg body weight. Adjunctive therapy in children aged 3 to 12 years — The dose may be increased as needed to a maximum of 40 mg/kg body weight per day. The total daily dose of this medicine should be divided into 3 doses.

This medication is an antiepileptic drug and may increase the risk of suicidal thoughts or behaviors, and mental health issues such as depression during treatment, so patients and caregivers should report any symptoms immediately to medical personnel. Stopping this medication abruptly can lead to more frequent seizures or a severe epileptic state, so dosage should be reduced gradually according to physician's instructions. This medication may cause serious side effects such as pancreatitis; therefore, if continuous upper abdominal pain, nausea, or repeated vomiting occurs, discontinue use immediately and visit a hospital. Also, in pediatric patients taking this medication, neuropsychiatric adverse reactions such as emotional instability, aggression, decreased concentration, and hyperactivity may occur, and careful observation is necessary. If this medication is taken with central nervous system depressants such as narcotics, severe drowsiness, respiratory depression, or coma may occur, so in such cases, it should only be taken at the lowest effective dose for a short duration under the guidance of a physician, with close monitoring of symptoms. It should not be administered to patients with hypersensitivity, acute pancreatitis, those with certain genetic lactose intolerance, or patients with primary generalized seizures. Patients with impaired kidney function, the elderly, those with a history of psychiatric illness, children with attention deficit disorder, and pregnant or breastfeeding women should use this medication with caution, and especially during pregnancy, risks to the fetus must be discussed with a doctor before use. Common side effects of this medication include dizziness, drowsiness, fatigue, nausea, vomiting, weight gain, movement disorders, visual disturbances, etc., and caution should be exercised while driving or operating hazardous machinery. Finally, during the use of this medication, prescribed directions for use and dosage should be strictly followed, and any concomitant use of other medications or alcohol should be discussed with medical personnel.

• suicidal impulses
• suicidal behavior
• depression
• abnormal changes in mood and behavior
• hemorrhagic pancreatitis
• emotional instability
• hostility
• abnormal thinking
• hyperactivity
• deep sedation

This medication may be sensitive to air or moisture, so it should be stored in a sealed container. It is best to maintain a storage temperature between 1 to 30 degrees Celsius. This will help preserve the effectiveness of the medication over time.

Appearance

An opaque capsule containing white or light gray powder.

Package unit

30 capsules/bottle, 100 capsules/bottle